DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
Device Problems
Charging Problem (2892); Connection Problem (2900)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/31/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.A getinge service territory manager (stm) was dispatched to investigate.The stm verified that the customer's biomed was able to correct the battery charging issue by reseating the iabp unit into the cart.In addition, the stm confirmed the adapter cable was not operating.The stm replaced the blood pressure transducer adapter cable to correct the issue.Subsequently, the stm completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.(b)(6).
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Event Description
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It was reported that during testing performed by the customer, the battery for the cardiosave intra-aortic balloon pump (iabp) was not charging when connected to ac power.In addition, the customer later reported that the blood pressure adapter cable was inoperative.There was no patient involved; thus, no adverse event reported.
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